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Imlunestrant Combo Approved for ESR1-Mutated Breast Cancer
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Fusion42 · 21 September 2026 · Fusion42 review
The FDA approved the combination of imlunestrant and abemaciclib for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after disease progression on at least one endocrine therapy. Alongside, the FDA approved the Guardant360 Liquid CDx test to detect ESR1 mutations via circulating tumor DNA.
This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 18 Sep 2026 and 21 Sep 2026.
◆ ◆ The Wire takeaway
You can now access a newly approved FDA treatment pathway for ESR1-mutated breast cancer that confirms mutation status through a liquid biopsy test. This expands your market opportunity to offer precision oral SERD-CDK4/6 therapies after endocrine therapy progression.
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10 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
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